Revitalizing oncology medications access in Saudi Arabia: Current challenges and recommendations by the Saudi Oncology Pharmacy Assembly.

BACKGROUND: Cancer care is posing immense challenges to healthcare systems globally. Advances in screening, monitoring, and treating cancer improved patient outcomes and survival rates yet amplified the disease burden. Multiple barriers might impede early access to innovative therapies. We thoroughly examined the current challenges in oncology medication access in Saudi Arabia and provided consensus recommendations to revitalize the process. METHODS: A focus group discussion was conducted. Expert healthcare providers (pharmacists and physicians) were invited to participate based on prespecified criteria. The research team conducted a qualitative analysis of the discussion to identify themes and formulate recommendations. RESULTS: Fourteen experts were equally distributed into two groups, limiting the number in each group to 7. Pharmacists were 12 (∼86%), and physicians were 2 (∼14%). Ten were practicing in governmental hospitals, four representing different sectors; regulatory bodies, including Ministry of Health, National Unified Procurement Company, and Saudi Food and Drug Authority. Five themes were identified: national cancer burden, local data availability, pharmacoeconomic evaluation, patients reported outcomes, administration, and procurement. Consensus recommendations were formulated to optimize the formulary management process, enabling informed decision-making and facilitating early medication access for cancer patients. CONCLUSIONS: The formulary management process can be enhanced by addressing the national cancer burden, promoting local data availability, conducting pharmacoeconomic evaluations, focusing on patient outcomes, and improving administration and procurement procedures. Implementing these recommendations can improve access to oncology medications and improve patient care outcomes in Saudi Arabia.

Atorvastatin in combination with radiotherapy and temozolomide for glioblastoma: a prospective phase II study.

Glioblastoma is a fast-growing primary brain tumor observed in adults with the worst prognosis. Preclinical studies have demonstrated the encouraging anticancer activity of statins. This study evaluated the efficacy of atorvastatin in combination with standard therapy in patients with glioblastoma. In this prospective, open-label, single-arm, phase II study, patients were treated with atorvastatin in combination with the standard glioblastoma therapy comprising radiotherapy and temozolomide. The primary endpoint was progression-free survival (PFS) at 6 months (PFS-6). Among 36 patients enrolled from January 2014 to January 2017, the median age was 52 (20-69) years; 22% of the patients were aged ≥60 years, and 62% were male. Patients received atorvastatin for a median duration of 6.2 (0.3-28) months. At a median follow-up of 19 months, the PFS-6 rate was 66%, with a median PFS of 7.6 (5.7-9.4) months. In terms of Grade ≥ 3 hematological adverse events, thrombocytopenia and neutropenia occurred in 7% and 12% of patients, respectively. In multivariate analyses, high baseline low-density lipoprotein levels were associated with worse survival (P = 0.046). Atorvastatin was not shown to improve PFS-6. However, this study identified that high low-density lipoprotein levels are an independent predictor of poor cancer-related outcomes. Future clinical trials testing statins should aim to enroll patients with slow-growing tumors.Clinical trial information: NCT0202957 (December 12, 2013).

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP).

Cancer is widely recognized as a major global health problem and is estimated to rank as one of the leading causes of death worldwide. Saudi Arabia has undergone remarkable socioeconomic development in the past 40 years which has contributed to the increase in cancer incidence. The high costs of new oncology medications in combination with uncertainty of long-term effectiveness and safety outcomes highlight the importance of considering value, in terms of clinical outcomes, relative to cost. We convened a group of experts to discuss key factors impacting the current state of cancer management in Saudi Arabia and to agree on a list of recommendations, with a focus on value-based care, considering evidence, patients, and costs.

Coping with the residency program during COVID-19: Hematology oncology pharmacy residents' perspective.

INTRODUCTION: The COVID-19 pandemic has led to significant changes in all governmental activities in Saudi Arabia including training and teaching, with the majority of such activities suspended in response to the COVID-19 pandemic. We aim to share the challenges that Hematology Oncology Pharmacy (HOP) residents faced during the quarantine period and provide recommendations on how to cope with the residency journey. METHOD: We followed a qualitative methodological approach in March 2020 using a structured virtual group discussion for data generation. RESULTS: All six PGY2 hematology oncology pharmacy (HOP) residents were included in the group discussion. The group agreed that the need for HOP services during this pandemic is beyond the scope of oncology pharmacists' normal daily practice. The group recognized two fundamental points. First, the goal of the current training should be customized to the most pressing need and recognized at the national level. Second, the current training system should be improved to ensure efficient use of current resources. On this basis, the group developed six main recommendations for action. CONCLUSION: The current situation is a challenge for all healthcare providers, and the majority of the nation's current generation never dealt with such a situation in days gone by. This paper presents the challenges that should be addressed at the national level and provide a fundamental consensus recommendation for practical approaches to maximize learning and minimize disruption to trainees' progression while maintaining patient-pharmacy quality of care.

Practical strategies to manage cancer patients during the COVID-19 pandemic: Saudi Oncology Pharmacy Assembly Experts recommendations.

PURPOSE: During COVID-19 pandemic, cancer patients are considered one of the most vulnerable to infection since they tend to have advanced age, multiple comorbidities, and are often immunosuppressed by their cancer or therapy. Hence, the Saudi Oncology Pharmacy Assembly has issued recommendations to reduce the frequency of cancer patients' visits to oncology centers during the pandemic while maintaining the access to cancer therapy and minimize the risk of exposure to coronavirus disease. MATERIALS AND METHODS: A qualitative methodological approach was conducted in April 2020 using a virtual panel discussion for collection of recommendations. RESULTS: A total of 12 expert oncology pharmacy practitioners shared their knowledge and experiences in managing oncology patients during the COVID-19 pandemic. The participants recognized many fundamental recommendations that were already applied in many cancer centers since the start of the COVID-19 outbreak. On that basis, the panelists developed eight practice-related recommendations for action, with a main focus on cancer treatment modification. CONCLUSIONS: In conclusion, delivering cancer care during the COVID-19 pandemic carries significant challenges. This paper addressed suggestions to properly manage cancer patients during difficult times. Implementing changes in practice mandates a national collaborative effort from different sectors to guarantee the quality and continuity of care. The SOPA expert panel developed these recommendations, to ultimately contribute in maintaining access to cancer therapy while minimizing the risk of COVID-19 exposure.

The use of 5-azacytidine in pregnant patient with Acute Myeloid Leukemia (AML): a case report.

BACKGROUND: The management of Acute Myeloid Leukemia (AML) during pregnancy remains challenging as both the maternal and fetal outcomes should be considered. Several reports suggested that chemotherapy can be administered safely during the second and third trimester of pregnancy. However, the use of 5-azacytidine presents limitation due to lack of data. CASE PRESENTATION: A 28-years-old woman in the 26th week of gestation diagnosed with FLT3/ITD-mutated AML, complete remission was induced by Daunorubicin and Cytarabine, and subsequently with 5-azacytidine (75 mg/m2 daily for 7 days) with no fetal hematological or toxicity issues. Fetal ultrasound showed no aberrant morphology. Fetal size below the 5th percentile with normal umbilical artery dopplers, normal middle cerebral artery dopplers and ductus venosus doppler. Three weeks post 5-azacytidine, the team determined the most appropriate time for delivery after balancing the risks of prematurity and prevention of disease relapse since patient in hematological remission. The patient underwent elective lower segment caesarian section and had a baby girl delivered at 35 weeks of gestation weighing 1670 g without apparent anomalies. CONCLUSION: Treatment using 5-azacytadine during last trimester of pregnancy resulted in no major fetal and maternal complications. These findings concluded that 5-azacytadine during the third trimester of pregnancy seems to be safe however, potential risks of this agent should be considered.

Barriers Facing Physicians in Opioids Prescribing for the Management of Moderate to Severe Pain in a Tertiary Care Center in Saudi Arabia.

Although several interventions are utilized for pain management, opioids remain the most effective intervention for moderate to severe pain. Despite opioids being the most potent analgesics used in different pain settings, several factors impede the optimal prescribing of opioids.The study seeks to identify and address the barriers physicians face to prescribing opioids in managing pain.This study was conducted in a tertiary care center in Riyadh, Saudi Arabia. It involved distributing questionnaires to the participants. The questionnaires sought to identify prescribers' knowledge and current practices as well as obstacles that they face when prescribing opioids. A total of 109 questionnaires were completed by participants.More than half [59.6%] of the respondents thought that opioid use was an optimal way to treat moderate to severe pain. About 33% chose "never" when asked if they fear legal sanctions when prescribing opioids. Fear of side effects limited almost 90% of the respondents from prescribing opioids.The study confirmed the perception that opioids are the most potent pharmacological intervention in treating pain. Several barriers were identified and discussed in this study. Further studies from different settings to understand these barriers are highly recommended.

Implementing Oncology Pharmacy Boot Camp for Advanced Pharmacy Practice Experience Students at a Regional Conference in Saudi Arabia.

Background Upon graduation, pharmacy students are expected to possess a diverse array of knowledge, skills, and attitudes. A subject-specific boot camp may support bridging the gap between the information and skills gained during clerkships, courses required for pharmacy school after graduation, and skills needed for the job market, as well as the gap between pharmacy school and residency. This research aimed to determine whether an integrated boot camp increased Advanced Pharmacy Practice Experience (APPE) student self-confidence and enhanced students' knowledge in oncology pharmacy. Method APPE students who attended the annual meeting of the Saudi Oncology Pharmacy Assembly (SOPA)/International Society of Oncology Pharmacy Practitioners (ISOPP) Regional Conference 2021 were voluntarily enrolled in a three-hour oncology-focused boot camp consisting of interactive lectures. Pre- and post-intervention examinations were used to evaluate student learning outcomes and their experience feedback. Result Of 118 students who attended the boot camp, 80 students who met the criteria were included in the study. The pre- and post-intervention examinations were completed by the 80 APPE students. The pre-intervention test results (mean: 66%, standard deviation (SD): 16%) increased by 21.5% after the boot camp (mean: 87.5%, SD: 12%, p = 0.001). Students scored better on each of the 10 test questions, with nine questions demonstrating a statistically significant result. Conclusion The results of this research showed that interns who participated in an oncology boot camp had a higher level of knowledge and confidence in applying key oncology concepts. Interns were satisfied with the chance to engage in the activity, and they agreed to adding boot camps to future conferences would be valuable. This research shows that it is possible to hold a transitional boot camp during conferences to better prepare students for their fields of study and increase their participation in oncology conferences.

Use of Thrombopoietin Receptor Agonists in Pregnancy: A Review of the Literature.

The management of immune thrombocytopenic purpura (ITP) involves several lines of therapy such as corticosteroids and intravenous immunoglobulin. With the emergence of novel therapies such as thrombopoietin receptor agonists (TPO-RAs), there has been a shift in treatment modalities. Eltrombopag and romiplostim have proven to be effective in the management of ITP through clinical studies, but their safety in pregnancy remains uncertain. The purpose of the study is to review the literature to evaluate the safety of TPO-RAs in pregnant women. Ten case reports and a cohort study pertaining to the use of TPO-RAs in pregnancy were obtained. According to the reported cases and prospective study, the use of eltrombopag and romiplostim appears to be relatively safe in the first, second, and third trimesters, as there were no reported congenital malformations. Low fetal birth weight has been observed following the administration of eltrombopag during the second trimester, whereas preterm birth has occurred following the administration of eltrombopag in the third trimester. Eltrombopag and romiplostim seem relatively safe. Further studies are necessary to clarify their safety during pregnancy.

Addressing Cancer Treatment Shortages in Saudi Arabia: Results of a National Survey and Expert Panel Recommendations.

PURPOSE: Cancer treatment shortages are complex and a persistent problem worldwide. Patients with cancer are most vulnerable to drug shortages, which provides opportunities to examine the extent of the challenge(s) facing Saudi Arabia and to provide recommendations toward mitigating the impact of cancer treatment shortages on patient outcomes. MATERIALS AND METHODS: A qualitative methodologic approach was conducted in April 2019 using a validated questionnaire and structured panel discussion for data generation. RESULTS: Overall, 55 responses were received from practicing oncology health care professionals (26 pharmacists and 29 physicians). The annual average number of treated patients with cancer per institution was 640 (adults [n = 400] and pediatric [n = 240]). All respondents (100%) reported that cancer treatment shortages constitute a current problem in their center, with an average of 5 (range, 1-9) per month. The panelists recognized 2 fundamental points. First, the definition of cancer drug shortages should be standardized and recognized at the national level. Second, the current system must be improved to ensure proper and efficient use of the current resources. On that basis, the panelists developed 9 recommendations for action. CONCLUSION: Cancer drug shortage is a significant problem in all health centers in Saudi Arabia. This study presents challenges that should be addressed at the national level and essential consensus recommendations for a coordinated action developed by a panel of experts to tackle the current national problem of cancer treatment shortages. Implementing these recommendations will provide a blueprint for management of national drug shortages in general and cancer treatment shortages in particular.